8. Women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized: 1. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation & the potential risk factors for an unintentional pregnancy; 2. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential; 3. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential & should practice an effective method of birth control; 4. Women & men must continue birth control for the duration of the trial & at least 3 months after the last dose of study drug;